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FDA 510(k)

URISYS 2400 URINE TEST STRIP

K-Number: K012397 · 2001-09-26

ApplicantRoche Diagnostics Corp.
Decision Date2001-09-26
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URISYS 2400 URINE TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-09-26 under 510(k) number K012397. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URISYS 2400 URINE TEST STRIP?

URISYS 2400 URINE TEST STRIP is a medical device that received FDA 510(k) clearance on 2001-09-26. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K012397.

When did URISYS 2400 URINE TEST STRIP receive FDA 510(k) clearance?

URISYS 2400 URINE TEST STRIP received FDA 510(k) clearance on 2001-09-26, under 510(k) number K012397.

Who is the listed applicant for URISYS 2400 URINE TEST STRIP?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URISYS 2400 URINE TEST STRIP?

The FDA product code for URISYS 2400 URINE TEST STRIP is JIL.

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Other records listing Roche Diagnostics Corp. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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